U.S. Court in Virginia Won’t Order FDA to Maintain Mifepristone Status Quo in Lawsuit Challenging Restrictions
- August 25, 2023
The U.S. District Court for the Western District of Virginia refused to issue a preliminary injunction to providers in Virginia, Kansas, and Montana requiring the Food and Drug Administration (FDA) not to alter the status quo as it relates to the availability of the abortion pill, mifepristone, during the pendency of their lawsuit.
According to the court, plaintiffs failed to establish that they would suffer irreparable harm without the injunction because there was no evidence the FDA intended to take any action to restrict the access of the drug in the three states.
The FDA approved the brand-name version of mifepristone in 2000 for medical termination of pregnancy. Mifepristone, taken in combination with a second drug misoprostol, is used to end a pregnancy through ten weeks gestation. Medication abortions now account for about half of abortions nationwide.
Mifepristone currently is subject to a Risk Evaluation and Mitigation Strategy (REMS), which the FDA updated in 2016, 2019, 2021, and 2023 to expand access to the drug, including increasing the indicated gestational age limit from 49 to 70 days, allowing a broader set of health care providers other than physicians to prescribe it, removing in-person dispensing requirements in favor of a pharmacy certification requirement, and allowing the drug to be delivered by mail.
Litigation related to mifepristone has been ongoing since the Supreme Court decision in Dobbs v. Jackson’s Health Org., 142 S. Ct. 228 (2022), finding the U.S. Constitution did not protect the right to an abortion.
In April 2023, the U.S. District Court for the Eastern District of Washington, in an action brought by attorneys general of 17 states and the District of Columbia, preliminarily enjoined the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone.” Washington v. U.S. Food and Drug Admin, No. 1:23-CV-3026-TOR (E.D. Wash. Apr. 7, 2023). The plaintiffs in that case, as in this case, are asking the court to strike down the mifepristone REMS.
More recently, the Fifth Circuit ruled that the abortion pill, including the generic version, should remain on the market but found the FDA improperly lifted restrictions with the 2016, 2021, and 2023 amendments to the REMS. Alliance for Hippocratic Med. v. Food and Drug Admin., No. 23-10362 (5th Cir. Aug. 16, 2023). The ruling, however, had no immediate impact on the availability of mifepristone since the Supreme Court in April ordered that the status quo under existing regulations remain while the litigation plays out.
Like in the Washington case, the plaintiffs in the instant action allege the mifepristone REMS creates unnecessary barriers to essential health care and seek a permanent injunction to enjoin the FDA from enforcing it.
Plaintiffs, however, also moved for a preliminary injunction preventing the FDA from altering the REMS as to mifepristone in Virginia, Montana, and Kansas. According to plaintiffs, even with the Supreme Court’s stay in Alliance, uncertainty surrounding the REMS is causing irreparable harm to them and their patients as they wait for further developments in that case.
But the court found plaintiffs failed to clearly establish they would suffer irreparable harm without preliminary relief. “Plaintiffs have offered no evidence that FDA intends to take action to change any of mifepristone's REMS or to restrict the access of the drug in Virginia, Kansas, or Montana.” Nor was there any evidence that the FDA “can promulgate regulations that would apply in certain states and not others, that it has ever done so, or that it intends to take such action.”
Moreover, the Court’s stay in the Alliance case means that mifepristone remains an available and viable medical option for health care professionals in the three states.
Whole Woman’s Health Alliance v. United States Food and Drug Admin., No.3:23-cv-00019 (W.D. Va. Aug. 21, 2023).